Self-inflating catheter with means to prevent leakage of inflation fluid



A nl 16, 1968 J. P.V1TELLO 7 SELF-INFLATING CATHETER WITH MEANS TOPREVENT LATION FLUID Filed June 23, 1965 LEAKAGE OF INF IN VENI ()R JOHNP \/\TELLO 11%; EH (F I IILFFII'EU United States Patent 3 378,011SELF-INFLATING CATHETER WITH MEANS TO PREVENT LEAKAGE 0F INFLATION FLUIDJohn P. Vitello, 198 Robin Hill Road, Williamsville, N.Y. 14221 FiledJune 23, 1965, Ser. No. 466,383 Claims. (Cl. 128349) ABSTRACT OF THEDISCLOSURE Theinflated distention fluid reservoir chamber of aself-inflating balloon catheter is snugly encased in a sac formed offluid impervious material to prevent fluid loss during storage.

This invention relates to self-inflating balloon catheters and pertainsmore particularly to means for prolonging the useful storage lifethereof.

Self-inflating bag catheters may conventionally employ water or otherliquid contained within an inflated, elastic reservoir tube which fluid,when released, is adapted to inflate the retention sleeve or bag of thecatheter device and so retain the same in proper position within thebladder of the patient after insertion of the catheter. The elasticreservoir tube is normally constructed of rubber or other suitableelastic material and although such materials are not normally propenseto leak fluid, there is a definite tendency for inflating fluid leakageto occur while the reservoir tube is in inflated condition. As a result,it may occur that during the normal storage time prior to use of suchcatheter devices that sufficient fluid leakage will occur as to renderthe device useless. This is a serious problem particularly in view ofthe fact that the precise amount of fluid contained within the inflatedreservoir tube is such that when released for inflating the retentionbag, a rather precise amount of fluid must be transferred to the bagarea for effecting distention thereof to the desired size. Obviously,then, no substantial degree of inflating fluid volume diminution can betolerated.

Attempts have been made to coat the inflated reservoir tube with asuitable material forming a sealant therefor but this solution is notentirely satisfactory owing to the fact that flaking and pealing away ofthe coating material or sealant occurs in response to the release of theinflating fluid to perform its bag or sleeve distending function. As aconsequence, flakes and strips of the coating sealant form debris whichare contaminants for an otherwise sterile field.

The resent invention is directed to a catheter device which overcomesthe above disadvantages and, more particularly, it is of primary concernin connection with this invention to provide an improved catheter deviceof the type generally specified hereinabove wherein the inflatedreservoir tube is enclosed or encased in a flexible yet substantiallyinelastic bag or sac which forms a barrier at the outer surface of theinflated portion of the reservoir tube.

More particularly, it is an object of this invention to provide abarrier or seal for the inflated reservoir tube of a self-inflating bagcatheter in which the sealing means is in the form of an enclosureagainst the inner surface of which the inflated reservoir tube isengaged to form, thereat, and substantially throughout the area of theinflated reservoir tube, a seal or barrier preventing the loss of fluidfrom the inflated reservoir tube and thus prolong the storage life ofthe catheter device' A further object of this invention resides in theprovision of a bulbous encasing sleeve or sac which is anchored in placeby the plug normally closing the open end of the reservoir tube andthrough which the inflating fluid is 3,378,011 Patented Apr. 16, 1968ice administered so that the bulbous sleeve is retained firmly in placeand in proper sealing relationship to the inflated reservoir tubeportion disposed therewithin.

A further object of this invention is to provide an assembly asdescribed in which the conventional plug for the reservoir tube isclamped and more securely held in place by the sealing means for thereservoir tube.

Other objects and advantages of this invention will appear from thespecification hereinafter and the accompanying drawing, wherein:

FIG. 1 is a plan view of a catheter constructed in accordance with thepresent invention and illustrating a portion of the sealing device andinflated reservoir tube broken away to show details of construction;

FIG. 2 is a longitudinal section taken through the assembly shown inFIGURE 1 but illustrating the reservoir tube in relaxed condition afterhaving expelled the inflating fluid therefrom to the anchor sleevedevice of the catheter;

FIG. 3 is a transverse section taken substantially along the plane ofsection line 3-3 and illustrating the sealing relationship between theinflated reservoir tube and the pouch or sac enclosing the same;

FIG. 4 is a transverse section taken substantially along the plane ofsection line 44 in FIGURE 2 showing the same assembly as in FIGURE 3 butwith the reservoir tube relaxed; and

FIGS. 5, 6 and 7 are views illustrating sequential operations in theformation of the sealing device.

With reference now more particularly to FIGURES 1 and 2, the catheterdevice therein is indicated generally by the reference character 10 andwill be seen to include a main shaft portion 12 provided, at its distalend, with a blunted tip or nose 14 having side drainage openings 16therein, the nose or tip 14 being rounded or otherwise smoothlyconfigurated so as to provide ease in insertion through the urethra ofthe patient. As can be best seen in FIGURE 2, the main shaft 12 isprovided with a drainage passage 18 extending to the tip 14 andcommunicating with the drainage openings 18 and, at the proximal end ofthe device, a drainage tube portion 20 is provided which is adapted tobe connected to any suitable drainage mechanism 22. The main shaft 12 isalso provided with an inflating lumen 24 which has an opening 26rearwardly of the tip 14. A sleeve or bag 28 is joined or otherwisesealed or fused with the shaft body 12 at opposite ends 30 and 32 of thesleeve to permit fluid under pressure in the distention lumen 24 toinflate the sleeve or bag 23 in the manner illustrated in FIGURE 2. Itwill be understood, of course, that the shaft 12 is inserted through theurethra sutficiently to place the tip 14 and the sleeve 28 within thepatients bladder so that when the bag 28 is inflated as shown in FIGURE2, the catheter is firmly anchored within the bladder so as to preventaccidental removal or retraction of the device.

The distention fluid lumen 24 communicates with a branched reservoirtube portion 34 which is provided, at its proximal end, with a plugmember 36 thereby closing the open end of the tube 34. Initially, thetube portion 34 is pinched ofl or closed by a suitable clamp device 38to allow inflation of the reservoir tube 34 between the mem ber 38 andthe plug 36 by the insertion of a hypodermic needle through the plug 36and the injection of a prescribed amount of fluid into the tube 34.This, of course, is entirely conventional and by reason of the fact thatthe catheter device is formed of elastic material, the elastic tube 34will swell and form a reservoir of pressurized fluid which, whenreleased by removal of a clamp 38, will inflate the bag 28 substantiallyas is shown in FIG- URE 2.

As has been stated, the problem encountered with catheter devices ofthis nature concerns the leakage of 3 the fluid from the inflatedreservoir tube 34 which, although relatively slow, neverthelessprohibits any lengthy storage time of the catheter device prior to itsuse. According to the present invention, a seal or barrier is providedat the outer surface of the distended portion of the tube 34 so as topreclude the gradual leakage of pressurizing fluid therefrom. The mannerin which this is accomplished specifically may be best seen by referenceto FIGURES 5-7 inclusive. As shown in FIGURE 5, the proximal end of thereservoir tube 34 is sandwiched between a pair of sheets 40 and 42constructed of substantially inelastic material such as polyvinylchloride, polyethylene or the like.

These sheets are then heat-sealed together as indicated by thecross-hatched areas 44 in FIGURE 6 so as to form collars 46 and 43 moreor less firmly engaging the reservoir tube 34 at spaced pointstherealong, the former collar 46 preferably embracing the large regionof the proximal end of the reservoir tube 34 within which the plug 36 isreceived. Ultimately, the sheets 40 and 42 may be trimmed away justoutside the heat-bonded regions thereof substantially as is shown inFIGURE 7. At this point, the relaxed reservoir tube, as is shown inFIGURE 4 is loosely housed within the barrier sac or bag 5t formed bythe process illustrated in FIGURES 5-f7 and the clamp device 38 isapplied at or near the collar portion 48 substantially as is shown inFIGURE 1 whereafter the pressurizing fluid is injected into the tube soas to cause the reservoir tube 34 to swell between the collar portions46 and 48 to the extent that the outer surface of the reservoir tubebetween such collar portions engages against the inner surface of thesac or bag 50. This effect is illustrated in FIGURES 1 and 3, thepressurizing fluid being indicated therein by the reference character52. A good, tight sealing barrier is formed by virtue of the fact thatthe sac or bag 50 is substantially inelastic as compared to thereservoir tube 34 so that the bag 50 is merely tightly inflated but notsignificantly distended. This effect also causes the reservoir tube 34to swell and very tightly engage with the collar portions 46 and 48 ofthe bag and, in effect, to be wedged therewithin so that throughout thedistended area of the tube 34, a sealing barrier is provided which willprevent the leakage of pressurizing fluid there from.

It will be noted that it is not essential that the clamp device 38 beengaged exactly on the collar 48 since it is only necessary that it beclose thereto. If the clamp device 38 is spaced from the collar 43 byonly a slight amount, the region of the reservoir tube between thecollar 48 and the device 38 will not swell and distend under theinfluence of the pressurizing fluid so that no problem of leakage willoccur thereat.

I claim:

1. In an inflatable bag catheter device of the type having an elongatemain shaft portion provided with a tip at its distal end and a drainagetube portion at its proximal end and a drainage passage communicatingsaid tip and said drainage tube portion, an elastic reservoir tubebranching from said main shaft portion, an inflatable sleeve surroundingsaid main shaft portion adjacent its distal end, and a distention fluidlumen communicating said reservoir tube with said sleeve, theimprovement comprising:

means for closing the proximal end of said reservoir tube,

releasable clamp means closing said reservoir tube at a point spacedfrom said means for closing the proximal end of the reservoir tube toform a fluid chamber therebetween,

a sealing bag enclosing a portion of said reservoir tube between saidreleasable clamp means and said means for closing said reservoir tube,and enclosing a volume substantially greater than the enclosed portionof the reservoir tube when relaxed, said bag being constructed of fluidimpervious and flexible but substantially inelastic material.

and a quantity of fluid in said chamber of an amount to expand theenclosed portion of said reservoir tube into contact throughout with theinner surface of said sealing bag.

2. In an inflatable bag catheter of the type having an elongate mainshaft portion provided with a tip at its distal end and a drainage tubeportion at its proximal end and a drainage passage communicating saidtip and said drainage tube portion, an elastic reservoir tube branchingfrom said main shaft portion, an inflatable sleeve surrounding said mainshaft portion adjacent its distal end, and a distention fluid lumencommunicating said reservoir tube with said sleeve, the improvementcomprising:

means blocking said reservoir'tube at spaced points thereon to define aninflating fluid chamber therebetween,

a quantity of fluid within said chamber of such amount as to inflatesaid tube,

and a sealing bag enclosing the inflated portion of said tube andcontacting the inflated portion of said tube throughout the outersurface thereof to form a sealing barrier at and throughout the outersurface of said inflated portion of said tube, said sealing bag beingconstructed of fluid impervious material.

3. In an inflatable bag catheter of the type having an an elongate mainshaft portion provided with a tip at its distal end and a drainage tubeportion at its proximal end and a drainage passage communicating saidtip and said drainage tube portion, an elastic reservoir tube branchingfrom said main shaft portion, an inflatable sleeve surrounding said mainshaft portion adjacent its distal end, and a distention fluid lumencommunicating said reservoir tube with said sleeve, the improvementcomprising:

means blocking said reservoir tube at spaced points thereon to define aninflating fluid chamber therebetween,

a quantity of fluid within said chamber of such amount to inflate saidtube,

and a substantially inelastic bag enclosing the inflated portion of saidtube and contacting the inflated portion of said tube throughout theouter surface thereof to form a sealing barrier at and throughout theouter surface of said inflated portion of the tube, said sealing bagbeing constructed of fluid impervious material.

4. In an inflatable bag catheter device of the type having an elongatemain shaft portion provided with a tip at its distal end and a drainagetube portion at its proximal end and a drainage passage communicatingsaid tip and said drainage tube portion, an elastic reservoir tubebranching from said said main shaft portion, an inflatable sleevesurrounding said main shaft portion adjacent its distal end, and adistention fluid lumen communicating saidreservoir tube with saidsleeve, the improvement comprising:

a pair of sheets of fluid impervious and substantially inelasticmaterial sandwiching a portion of said reservoir tube therebetween, saidsheets being joined together to present necked portions snugly engagingsaid reservoir tube at spaced points thereon and intervening portionsbetween said necked portions which allow inflation of the reservoir tubebetween the necked portions,

means blocking said reservoir tube substantially at said spaced pointsto define an inflating fluid chamber,

and a quantity of fluid in said chamber of an amount to expand saidreservoir tube into contact throughoutwith the inner surfaces of saidsheets.

5. In an inflatable bag catheter device of the type having an elongatemain shaft portion provided with a tip at its distal end and a drainagetube portion at its proximal end and a drainage passage communicatingsaid tip and said drainage tube portion, an elastic reservoir tubebranching from said main shaft portion, an inflatable 5 6 sleevesurrounding said main shaft portion adjacent its into sealing contactthroughout with the bulbous distal end, and a distention fiuid lumencommunicating inner surfaces of said sac. said reservoir tube with saidsleeve, the improvement comprising: References Cited a substantiallyinelastic sac enclosing a portion of said 5 UNITED STATES P ATENTSreservoir tube, said sac having a necked down portion at its oppositeends engaging spaced points along 8 the reservoir tube and being bulboustherebetween, 3275O01 9/1966 g 128349 said sac being constructed offluid impervious rnaterial, w 3,235,069 2/1966 Bennett et a1. 206--632means for blocking said reservoir tube adjacent said O HER REFERENCESneifksd down P0111011S of the sac to define an inflating Foley, ASelf-Inflating Bag Catheter, Jour. of Urolfimd chamber therebetween"ogy, November 1962, vol. 88, pp. 724-728.

and a quantity of fluid in said chamber in an amount to expand theenclosed portion of said reservoir tube 15 DALTON L. TRULUCK, PrimaryExaminer.

Disclaimer 3,378,011.-Jolm P. Vitello, Williamsville, N.Y.SELF-INFLATING CATH- ETER \VITH MEANS TO PREVENT LEAKAGE OF INFLA- TIONFLUID. Patent dated Apr. 16, 1968. Disclaimer filed June 26, 1970, bythe inventor and the assignee, Sterilon Corporation. Hereby enter thisdisclaimer to claim 2 of said patent.

[Official Gazette August 25, 1970.]

